A study to assess possible drug-drug interactions between MDV3100 and gemfibrozil and MDV3100 and Itraconazole.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
41
SGS
Paris, France
Assessment of pharmacokinetic profile of MDV3100 by Cmax (Maximum concentration)
Time frame: Day 1 through Day 53 (29 times)
Assessment of pharmacokinetic profile of MDV3100 by AUCinf (AUC extrapolated to infinity)
Time frame: Day 1 through Day 53 (29 times)
Assessment of pharmacokinetic profile of MDV3100 by AUC0-432h (AUC from the time of dosing to 432 hours post-dose)
Time frame: Day 1 through Day 53 (29 times)
Assessment of pharmacokinetic profile of MDV3100
tmax (Time to attain Cmax), t1/2 (Apparent terminal elimination half life), Vz/F (Apparent volume of distribution during the terminal phase after extra vascular dosing) and CL/F(Apparent total body clearance after extra vascular dosing)
Time frame: Day 1 through Day 53 (29 times)
Assessment of pharmacokinetic profile of the metabolites MDPC0001 and MDPC0002
Cmax, AUC0-432h, tmax, t1/2, and AUC0-inf
Time frame: Day 1 through Day 53 (29 times)
Assessment of metabolite-to-parent ratios for MDV3100
This may additionally be reported to assess effects on particular enzyme pathways
Time frame: Day 1 through Day 53 (29 times)
Assessment of Gemfibrozil and gemfibrozil 1-O-β-glucuronide (Arm 2)
Cmax, C0h, Cmin, tmax, AUCtau
Time frame: Day 1 through Day 53 (50 times)
Assessment of itraconazole and hydroxyitraconazole (Arm 3)
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Cmax, C0h, Cmin, tmax, AUCtau
Time frame: Day 1 through Day 53 (50 times)
Safety as assessed by recording adverse events, laboratory assessments, vital signs and electrocardiograms (ECGs)
In arm 3, liver function tests (AST, ALT, GGT, total bilirubin) will be done regularly during itraconazole dosing
Time frame: Day 1 through Day 53